Reference: REGD-0007337

Version: 6.0; Most-Recent; Effective; CURRENT

Status: Effective Purpose: Uncontrolled Copy
Class: Control del Diseño Effective date: 29-oct-2012
Title: SM DG57-DG517. Operation qualification.

DG57 / DG517
Service Manual

OPERATION QUALIFICATION

Procedure description
Operation Qualification (OQ) testing is performed to verify that the instrument or instrument modules
operate as intended.

Note: Document REGD-0007337_v5 replaces document REGD-0007337_v4.

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Print date: 31-oct-2012 Page 2 of 7
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 Reference: REGD-0007337
Version: 6.0; Most-Recent; Effective; CURRENT
Status: Effective Purpose: Uncontrolled Copy
Class: Control del Diseño Effective date: 29-oct-2012
Title: SM DG57-DG517. Operation qualification.

OPERATION QUALIFICATION (OQ).

Operation qualification REGD-0007337 is related to DG-57 service manual (REGD-0000749)

and DG-517 service manual (REGD-0009629).

First of all, ensure that the mains switch, which is located in the back side of the instrument, is
turned off. Then plug the mains cable, supplied with the instrument, to the DG-57/ DG-517 first
and to the mains later.

DANGER!
Electromagnetic compatibility and electrical safety tests have
been performed using the cord supplied by the
manufacturer. Using cables different to the one supplied may
degrade the performances of the instrument concerning
electromagnetic compatibility and safety.

NOTE:
If the instrument has been stored under different
environmental conditions than the operation conditions, wait
for at least 1 hour under the operation conditions before
turning the instrument on.

Before turning the instrument on, check that the empty waste bottle is connected and both wash
solution bottles are filled with expected solutions and connected. Check also that the card waste
container is placed correctly.

Instrument: DG57 / DG517 Form version: 6.0

Serial number: Code:
Installation date: Qualification Date:

Customer Site: Customer Name:

Department:

Tel: Fax: E-Mail:

Service Engineer Name:

Department:

Tel: Fax: E-Mail:

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 Reference: REGD-0007337
Version: 6.0; Most-Recent; Effective; CURRENT
Status: Effective Purpose: Uncontrolled Copy
Class: Control del Diseño Effective date: 29-oct-2012
Title: SM DG57-DG517. Operation qualification.
1 Connect:
 DG-57 / DG-517.
 Computer.

Computer Model:
Serial Number:

 Monitor, keyboard, mouse.

 Printer.
 UPS
Serial Number:
 Manual Barcode reader.

2 Check computer:
 Operating System installed:

Operating system
Version:

 Diana System software installed:

Software. Versión.
WADiana C.
Diana R.
Diana O
Diana Server.
WADDiagnostic.

 Matrox Video card installed).

Matrox Model:
Visio DLL version:

3 Reference image (REGD-0000814).

 Generate a reference image.

 Reference image Printed and attached (if printer available).

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 Reference: REGD-0007337
Version: 6.0; Most-Recent; Effective; CURRENT
Status: Effective Purpose: Uncontrolled Copy
Class: Control del Diseño Effective date: 29-oct-2012
Title: SM DG57-DG517. Operation qualification.
4 WADDiagnostic.

Module Pass Comments

Communications.
Settings.
Initializations.
Motor Movements.
Vaccum/Pressure.
Temperature Regulation.
Tubes identification.
Reagents identification
Level detection.
Cards transport.
Cards reading.
Centrifugation.
Centrifuge balancing
detector.
Solutions bottles level.
Fluid circuit.
Pipeting.
Door, leds and buzzer.

Note: In case of running WADDiagnostic on DG-517 or DG-57 S/N ≥ 057-0004285 ‘centrifuge

balance detector’ step will not apply (Comments NA).

 Check that holes in the dispensed card film are centered in Y axis and
shifted about 1mm to the left part of the instrument in X axis.

 WADDiagnostic report attached (if printer available).

4 Print and attach calibValues.txt (if printer available).

5 Place a balance card inside balance card position.

6 Temperature.
(REGD-0000799 Checking the adjust of the incubator module)

6.2 37ºC:

Block Measured Temp. Spected Temp. Acceptable

Block 1 37ºC± 1ºC
Block 2 37ºC± 1ºC

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 Reference: REGD-0007337
Version: 6.0; Most-Recent; Effective; CURRENT
Status: Effective Purpose: Uncontrolled Copy
Class: Control del Diseño Effective date: 29-oct-2012
Title: SM DG57-DG517. Operation qualification.
6.3 24ºC:

Measured Temp. Spected Temp.

Block Acceptable
Block 1 24ºC± 3ºC
Block 2 24ºC± 3ºC

7 Centrifuge speed and time (REGD- 0000832):

Measured Spec. Speed Measured Spec. time (s)

Speed (rpm) (rpm) time (s) Acceptable
992 ± 5 614 ± 10

8 Reagents spinning (REGD- 0000797):

Speed Spec. Speed (rpm)

Measured Speed (rpm)
Slow Speed > 100
Fast Speed > 400
Fastest Speed > 500

 All carrousel reagent positions are able to spin.

9 Real batch test acceptable:

User / Operator run a real batch to check overall performance execution (i.e.: ABO-
Rh profile). For negative results, check that the size of the button is homogeneous
between wells.

Comments:

Service Engineer signature: Customer signature:

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 Reference: REGD-0007337
Version: 6.0; Most-Recent; Effective; CURRENT
Status: Effective Purpose: Uncontrolled Copy
Class: Control del Diseño Effective date: 29-oct-2012
Title: SM DG57-DG517. Operation qualification.
DOCUMENT CHANGE HISTORY

Document change history

Version Date Change Rationale
See document Replaced commercial name by Delete commercial name.
4.0
header. project name.
Note: Document Document version changed.
4.0 2011/05/18 REGD-0001337_v4 replaces
document REGD-0001337_v3.
Added ‘procedure description’ Unify service manual documents style.
4.0 2011/05/18
section.
Updated ‘check computer’ point: Unify OQ to DG-57/DG517.
- Deleted REGD documents
4.0 2011/05/18 reference.
-Modified ‘Matrox video card
installed’ section
Update ‘WADDiagnostic’ point: Unify OQ to DG-57/DG517.
- Deleted REGD documents
4.0 2011/05/18 reference.
-Deleted ‘clot detection’ step.
-Added ‘Note’.
Header title has changed. Previous header title has been
4.0 2011/05/18 substituted by project and document
title.
Added service manual index Document related to service manual.
5.0 2011/09/20
references.
2011/09/20 Added qualification date. Qualification date can be different than
5.0
installation date.
2011/09/20 Added number of pages. Number of pages in the page bottom
5.0
side.
2011/09/20 Description simplified. Procedure description section only
5.0
describes the procedure.
Updated WADdiagnostic note ‘centrifuge balance detector’ checking
See document
6.0 will also not apply to DG-57.
header.
See document Corrected holes dispensed card film Ensure correct card dispensed position.
6.0
header. checking.
See document Added reagents spinning Ensure correct reagents spinning.
6.0
header. verification.

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